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Active, Not Recruiting

NCT Number: NCT07014280

Bevacizumab Versus Triamcinolone Acetonide for the Treatment of Keloids.

The study compares the efficacy and safety of intralesional bevacizumab versus corticosteroids for the treatment of keloids. Assessment will be done clinically by the use of Modified Vancouver Scar Scale. Erythema index will be measured by spectrophotometry. The levels of Vascular Endothelial Growth Factor, collagen type 1 and collagen type 3 in the lesions before and after each treatment modality.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Kasr El Ainy University Hospital, faculty of medicine, Cairo university

Cairo, El Manial, 11956, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with keloids (post-traumatic, any site, any duration)
  • Age >18 years
  • Patients who didn't receive any treatment for the lesions in the past 6 weeks

Exclusion criteria

  • Patients who are pregnant, willing to get pregnant or lactating
  • History of any liver or renal disease
  • History of any cardiovascular disease
  • History of hypertension
  • History of thrombo-embolic events
  • Known cases of bleeding disorders
  • History of peptic ulcer
  • Patients who underwent any surgeries in the last month

Treatment and study plan

Bevacizumab

Drug

anti-VEGF

Triamcinolone Acetonide

Drug

corticosteroid

Primary outcomes

  1. Modified Vancouver scar scale (mVSS)

    Time frame: 6 months

    Six characteristics of the scar were assessed. These are: vascularity, height, pliability, and pigmentation, pain and pruritis. Each characteristic is given a score, which are added together to give an overall score between 0 and 18. Higher scores mean a worse outcome.

  2. Erythema Index

    Time frame: 6 months

    Evaluation of skin erythema index was done using a spectrophotometry device

  3. Vascular Endothelial growth factor (VEGF)

    Time frame: 6 months

    Tissue levels of VEGF, collagen type 1 and 3 measured by Enzyme linked immunosorbent assay

  4. Collagen type 1 and 3

    Time frame: 6 months

    Tissue levels of collagen type 1 and 3 measured by Enzyme linked immunosorbent assay

  5. Histopathological examination

    Time frame: 6 months

    Two mm punch biopsies were obtained per area at baseline and one month after the last treatment session. The post-treatment biopsy 3as taken from the vicinity of the baseline biopsy. Tissues are fixed in 10% buffered formalin, embedded in paraffin and sectioned into 5 μm-thick sections. Specimens were stained with hematoxylin and eosin (H&E) and orcein (or demonstration of elastic fibers). Histological examination was carried out under a light microscopy. Assessment was done as follows:

    • Assessment of the collagen fibers will be done by examining H & E slides, putting grading from 1 to 4 according to the thickness and orientation of the collagen fibers and the spaces in between the fibers.
    • Assessment of the elastic fibers will be done through examining orcein stained specimens and grading the elastic fibers in the scars from 1 to 4 based on presence or absence of the elastic fiber and degree of degradation and fragmentation.

Sponsors and collaborators

Lead sponsor

Kasr El Aini Hospital

Other

Registry information

Official study title

Efficacy of Intralesional Bevacizumab Versus Intralesional Triamcinolone Acetonide Injection in the Treatment of Keloids.

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Jun 10, 2025
Registry last updated
Jun 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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